FDA.reportPublic FDA data

Application 074597

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDETABLET;ORAL8MGNoNo
003HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDETABLET;ORAL4MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0264Hydromorphone Hydrochloridehydromorphone hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0264Hydromorphone Hydrochloridehydromorphone hydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0264Hydromorphone Hydrochloridehydromorphone hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0265Hydromorphone Hydrochloridehydromorphone hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0265Hydromorphone Hydrochloridehydromorphone hydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0265Hydromorphone Hydrochloridehydromorphone hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22346ORIG2007-04-02
30685ORIG1998-07-29